The European Parliament has set forth new regulatory requirements for post-market surveillance (PMS). The current In Vitro Diagnostic Directive (IVDD) will be replaced with the In Vitro Diagnostic Regulation (IVDR) which will fully apply May 26, 2022.
Current global PMS guidelines and regulations are generally limited to complaint management, vigilance reporting, and recall management. However, this is changing and the IVDR will put more responsibility on the manufacturer to become proactive and continuously monitor device data in order to keep the benefit-risk profile current. Improved PMS actions will include Periodic Safety Update Reporting (PSUR).
The transition from IVDD to IVDR will pose a big challenge for medical device and in vitro diagnostic manufacturers that distribute products within the EU.
Transitioning from reactive to proactive data gathering
Technological advancement has made it possible to secure automatic connectivity, data collection and analysis. These technological advancements have enabled proactive data gathering and analysis rather than relying on reactive data gathering (e.g. once a post-market event has been reported) that has changed post-market surveillance (PMS) plans significantly. This shift has also been emphasized by Regulatory authorities that set focus on reactive measures.
MedTech/IVDR companies have now begun to adopt this technology shift and regulatory demand to secure their future by adopting data driven business model. This will increase their competitive advantage, decrease cost, reduce risk and create additional value for their end-customers.
New PMS activity requirements under IVDR 2022
Even (previously IVDD compliant) manufacturers who also are ISO13485:2016 compliant will be affected by the IVDR since Article 78 (The Guide for Post-Market System of the Manufacturer) has more detailed requirements than what is stated by the standard.
To be compliant all manufacturers must have a PMS system under IVDR, and data must be utilized as outlined in Article 79 (3):
- Updates to the benefit-risk determination and to improve risk management (Annex I Chapter 1)
- Update the design and manufacturing information, the instructions for use and the labelling
- Update the performance evaluation
- Update the summary of safety and performance referred to in Article 29
- Identification of preventive, corrective or field safety corrective action
- Identification of ways to improve the device by improving the usability, performance and safety of the device
- When relevant, to contribute to the post-market surveillance of other devices
- To detect and report trends in accordance with Article 83
Due to these requirements, it is important that surveillance programs are implemented with a formal Post-Market Surveillance Plan (PMSP). It shall be shown that data collected is consistently and regulatory updated to the PMS, risk report, technical documentation and performance evaluations. Furthermore, the importance of proactive actions based on early detections and trends are required by regulation as illustrated and described below.
Medical cloud IT systems, process transformation and organizational alignment is needed
The old way (“reactive data gathering”) to meet the regulations for PMS compliance has typically been managed by, and met by, Quality Assurance or Regulatory Affairs. However, these departments have poor and manual data communication channels with manufacturer’s QA/RA Management Systems, Service Management, and most importantly external channels and direct communication/data gathering with end-customers and the devices they use.
External channels, including distributors/agents/partners (OEM) often represent a significant percentage of a device company’s sales, however, they generally have poor processes to collect and communicate data that may impact safety and have poor traceability of product.
The significant “digitalization” gaps within MedTech/IVDR companies require customized medical cloud IT systems that align with process transformation and organizational alignment. Immature and non-flexible off-the-shelf systems will not fulfill the individual need of the MedTech/IVDR companies.
A safe data collection and correct data exchange agreement with distributors in a regulated global world for improved data collection and data analytics is not an easy task. PMS must be designed to generate useful information on the device based on real-life usage data, enabling proactive data gathering and analysis. Current standards and guidance information on PMS reflect this reality.
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